An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial

Louise Fleng Sandal, Mette Jensen Stochkendahl, Malene Jagd Svendsen, Karen Wood, Cecilie K Øverås, Anne Lovise Nordstoga, Morten Villumsen, Charlotte Diana Nørregaard Rasmussen, Barbara Nicholl, Kay Cooper, Per Kjaer, Frances S Mair, Gisela Sjøgaard, Tom Ivar Lund Nilsen, Jan Hartvigsen, Kerstin Bach, Paul Jarle Mork, Karen Søgaard

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Abstract

Background: Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. Objective: The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. Methods: This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. Results: The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020.Conclusions: This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions.

Original languageEnglish
Article numbere14720
JournalJ M I R Research Protocols
Volume8
Issue number12
ISSN1929-0748
DOIs
Publication statusPublished - 3. Dec 2019

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Low Back Pain
Randomized Controlled Trials
Mobile Applications
Exercise
Control Groups
Developed Countries
Developing Countries
Primary Health Care
Age Groups
Delivery of Health Care

Keywords

  • App
  • Case-based reasoning
  • Decision support system
  • Low back pain
  • Self-management
  • eHealth
  • mHealth

Cite this

Sandal, Louise Fleng ; Stochkendahl, Mette Jensen ; Svendsen, Malene Jagd ; Wood, Karen ; Øverås, Cecilie K ; Nordstoga, Anne Lovise ; Villumsen, Morten ; Rasmussen, Charlotte Diana Nørregaard ; Nicholl, Barbara ; Cooper, Kay ; Kjaer, Per ; Mair, Frances S ; Sjøgaard, Gisela ; Nilsen, Tom Ivar Lund ; Hartvigsen, Jan ; Bach, Kerstin ; Mork, Paul Jarle ; Søgaard, Karen. / An App-Delivered Self-Management Program for People With Low Back Pain : Protocol for the selfBACK Randomized Controlled Trial. In: J M I R Research Protocols. 2019 ; Vol. 8, No. 12.
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title = "An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial",
abstract = "Background: Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. Objective: The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. Methods: This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. Results: The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020.Conclusions: This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions.",
keywords = "App, Case-based reasoning, Decision support system, Low back pain, Self-management, eHealth, mHealth",
author = "Sandal, {Louise Fleng} and Stochkendahl, {Mette Jensen} and Svendsen, {Malene Jagd} and Karen Wood and {\O}ver{\aa}s, {Cecilie K} and Nordstoga, {Anne Lovise} and Morten Villumsen and Rasmussen, {Charlotte Diana N{\o}rregaard} and Barbara Nicholl and Kay Cooper and Per Kjaer and Mair, {Frances S} and Gisela Sj{\o}gaard and Nilsen, {Tom Ivar Lund} and Jan Hartvigsen and Kerstin Bach and Mork, {Paul Jarle} and Karen S{\o}gaard",
note = "{\circledC}Louise Fleng Fleng Sandal, Mette Jensen Stochkendahl, Malene Jagd Svendsen, Karen Wood, Cecilie K {\O}ver{\aa}s, Anne Lovise Nordstoga, Morten Villumsen, Charlotte Diana N{\o}rregaard Rasmussen, Barbara Nicholl, Kay Cooper, Per Kjaer, Frances S Mair, Gisela Sj{\o}gaard, Tom Ivar Lund Nilsen, Jan Hartvigsen, Kerstin Bach, Paul Jarle Mork, Karen S{\o}gaard. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.12.2019.",
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An App-Delivered Self-Management Program for People With Low Back Pain : Protocol for the selfBACK Randomized Controlled Trial. / Sandal, Louise Fleng; Stochkendahl, Mette Jensen; Svendsen, Malene Jagd; Wood, Karen; Øverås, Cecilie K; Nordstoga, Anne Lovise; Villumsen, Morten; Rasmussen, Charlotte Diana Nørregaard; Nicholl, Barbara; Cooper, Kay; Kjaer, Per; Mair, Frances S; Sjøgaard, Gisela; Nilsen, Tom Ivar Lund; Hartvigsen, Jan; Bach, Kerstin; Mork, Paul Jarle; Søgaard, Karen.

In: J M I R Research Protocols, Vol. 8, No. 12, e14720, 03.12.2019.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - An App-Delivered Self-Management Program for People With Low Back Pain

T2 - Protocol for the selfBACK Randomized Controlled Trial

AU - Sandal, Louise Fleng

AU - Stochkendahl, Mette Jensen

AU - Svendsen, Malene Jagd

AU - Wood, Karen

AU - Øverås, Cecilie K

AU - Nordstoga, Anne Lovise

AU - Villumsen, Morten

AU - Rasmussen, Charlotte Diana Nørregaard

AU - Nicholl, Barbara

AU - Cooper, Kay

AU - Kjaer, Per

AU - Mair, Frances S

AU - Sjøgaard, Gisela

AU - Nilsen, Tom Ivar Lund

AU - Hartvigsen, Jan

AU - Bach, Kerstin

AU - Mork, Paul Jarle

AU - Søgaard, Karen

N1 - ©Louise Fleng Fleng Sandal, Mette Jensen Stochkendahl, Malene Jagd Svendsen, Karen Wood, Cecilie K Øverås, Anne Lovise Nordstoga, Morten Villumsen, Charlotte Diana Nørregaard Rasmussen, Barbara Nicholl, Kay Cooper, Per Kjaer, Frances S Mair, Gisela Sjøgaard, Tom Ivar Lund Nilsen, Jan Hartvigsen, Kerstin Bach, Paul Jarle Mork, Karen Søgaard. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.12.2019.

PY - 2019/12/3

Y1 - 2019/12/3

N2 - Background: Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. Objective: The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. Methods: This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. Results: The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020.Conclusions: This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions.

AB - Background: Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP. Objective: The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP. Methods: This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. Results: The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020.Conclusions: This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions.

KW - App

KW - Case-based reasoning

KW - Decision support system

KW - Low back pain

KW - Self-management

KW - eHealth

KW - mHealth

U2 - 10.2196/14720

DO - 10.2196/14720

M3 - Journal article

C2 - 31793897

VL - 8

JO - J M I R Research Protocols

JF - J M I R Research Protocols

SN - 1929-0748

IS - 12

M1 - e14720

ER -